mycophenolate mofetil (mmf) in patients with iga nephropathy (igan)

Conditions: IgA Nephropathy

Summary: a multi-center, randomized, controlled clinical trial to evaluate the short-term and long-term efficacy and safety of mycophenolate mofetil (mmf) in reducing proteinuria and preserving renal function in patients with igan who have pre-treated (and continue to be treated) with angiotensin ii receptor blockers (arb), compared to the corticosteroids.

there are four phases of study for each subject. phase 1 the screening phase. during this phase each potential subject will be evaluated to determine if he/she is eligible for the study. phase 2 the arb lead-in phase will last for three months. phase 3 the intervention phase. each subject will be randomly received 12 months treatment with the study drugs (mmf, prednisone or mmf plus prednisone) phase 4 following-up phase. all the patients will be followed by 3 years after study drug stopped.

Eligibility criteria:
inclusion criteria: * willingness to sign an informed consent * age:14\~60 years, regardless of gender * clinical evaluation and renal biopsy diagnostic for igan, excluded secondary igan. renal histological criteria should be defined by lee's glomerular grading system. * 1 g/day \<= proteinuria \< 3.5 g/day, or upr/cr ratio ≥ 0.6 (male) or ≥ 0.8 (female) when taking arb * egfr ≥ 40 ml/min/1.73 m2 exclusion criteria: * inability or unwillingness to sign the informed consent * inability or unwillingness to meet the scheme demands raised by the investigators * rapidly progressive nephritic syndrome and acute renal failure, including rapidly progressive igan ( igan with rapid decline in renal function characterized histologically by necrotizing vasculitis and crescent formation≥30%) necessitating the use of other immunosuppressive agents. * secondary igan such as systemic lupus erythematosus, henoch-schonlein purpuric nephritis and hepatitis b -associated nephritis * est gfr \< 40 ml/min/1.73m2 * malignant hypertension that is difficult to be controlled by oral drugs * cirrhosis, chronic active liver disease. * history of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease.) * any active systemic infection or history of serious infection within one month of entry or known infection with hiv, hepatitis b, or hepatitis c. * other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure , chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases) * malignant tumors (except fully cured basal cell carcinoma) * absolute neutrophil count \< 1500／mm3, absolute platelet count \<75000／mm3 or hematocrit (hct) \<28% (anemic subjects may be reevaluated after the anemia has been treated.) * known allergy, contraindication or intolerance to the mmf, corticosteroids or acei/arb. * pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception * current exposure to mmf or azathioprine. in case of current treatment with oral steroid or acei/arb, entry is permitted after corticosteroids or acei/arb are stopped for 2 weeks. * current or recent (within 30 days) exposure to any other investigational drugs

Keywords: iga nephropathy mycophenolate mofetil